Industry News: Managing Complexity

Source Clinical Trials Arena: February 23, 2016

As cited by Antoine Freyss of Novartis in a recent Clinical Trials Arena article, “Welcome IRT to Your Clinical Trials,” analysis of trends within clinical trials shows an exponential growth in study registrations over the past decade.

The FDA (Food and Drug Administration) declared an average of 3,900 trial registrations per year from 2000 to 2005 compared to an average of 18000 registrations per year from 2006 to 2015 (source: www.ClinicalTrials.gov)! Alas, with major growth comes major growing pain, and an increasing need to find tools and processes that can help manage the flow of product, subjects, sites, and data. Freyss raises the question: "How can clinical operations take up this challenge in an efficient and cost-effective manner"? He points to the use of Interactive Response Technology (IRT = IWRS/IVRS) to help manage the heavy load of clinical trial activities, including:

IRT for Patient Randomization

Freyss points out, “Most evolved IRT systems can nowadays support most complex randomization techniques, such as Static Randomization, Covariate Adaptive Randomization and Responsive Adaptive Randomization. This automated and computerized process enables organizations to get rid of the old fashioned and fusty randomization by packaging which was leading to a great waste of medication and less robust blinding.” More

IRT for Real-Time Drug Allocation

“Treating patients on time, every time, with the right drug while keeping the study blind is not an easy task without help of an IRT system,” Freyss notes. “Drug allocation via IRT is a good example of showing how necessary it is to use an interactive system.” More

IRT for More Accurate Drug Supply

Freyss focuses, too, on the issue of drug supply management, made easier by using an IRT. He notes, “The industry suffers from a lack of drug supply forecasting expertise, and to alleviate risk of running out of stock sponsors tend to overproduce and over supply depots and centers. This overage represents a huge cost in phase III trials (for example) where a numerous number of sites across the globe are participating. The reduction of the overage with the help of IRT will largely balance the cost of building an IRT system.”